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CompletedNCT00634985Updated Jan 27, 2021

Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-inflammatory Drugs

A Phase 4 interventional study of eletriptan in Migraine, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 6 sites in Turkey. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-01-27.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

To assess the safety and efficacy of eletriptan for the treatment of migraine in subjects who had not been adequately treated with non-steroidal antiinflammatory drugs (NSAIDs)

02

Conditions studied

  • Migraine

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03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 120 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Met International Headache Society diagnostic criteria for migraine with or without aura
  • Expected to suffer one to six acute migraine attacks per month based on past history
  • Experienced migraines for at least one year prior to entering study, and historically have not responded to NSAIDs

Exclusion criteria

Exclusion Criteria:

  • Frequent migraine or frequent concomitant non-migrainous headache (average of >6 attacks per month)
  • Atypical migraines that consistently failed to respond to adequate medical therapy
  • Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, or migraine with acute-onset aura
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    A

    Drug: eletriptan

Interventions

  • Drugeletriptan

    40 mg oral tablet for migraine attack; additional 40 mg oral tablet \>2 hours from first dose if migraine reoccurred within 24 hours of achieving response

06

What researchers measure

Primary outcomes

  1. Headache severity and response post-treatment

    Time frame: 2 hours

  2. Functional response post-treatment

    Time frame: 2 hours

Secondary outcomes

  1. Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment

    Time frame: 1, 2, 4, and 24 hours

  2. Migraine recurrence post-treatment

    Time frame: 1, 2, 4, and 24 hours

  3. Time loss (from normal activities and from work) post-treatment

    Time frame: 24 hours

  4. Subject preference and acceptability post-treatment

    Time frame: 24 hours and 12 weeks

  5. Subject satisfaction post-treatment

    Time frame: 2 and 24 hours

  6. Adverse events

    Time frame: Week 12

  7. Physical examination

    Time frame: Week 12

  8. Vital signs

    Time frame: Week 12

  9. Electrocardiogram

    Time frame: Week 12

  10. Headache severity and response at baseline and post-treatment

    Time frame: 1, 4 and 24 hours

  11. Functional impairment severity and response at baseline and post-treatment

    Time frame: 1, 4 and 24 hours

07

Study locations

6 sites
  • Pfizer Investigational Site
    Capa, Istanbul, Turkey
  • Pfizer Investigational Site
    Gaziantep, Turkey
  • Pfizer Investigational Site
    Istanbul, Turkey
  • Pfizer Investigational Site
    Izmir, Turkey
  • Pfizer Investigational Site
    Samsun, Turkey
  • Pfizer Investigational Site
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00634985
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
First posted
Mar 13, 2008
Start date
Nov 2002
Completion
Dec 2003
Last update
Jan 27, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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